MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: at analysis it was determined the programmer¿s stylus tip was loose and difficult to use.Analysis also noted that the power cord bay was broken, keyboard space bar was missing, keyboard hinges were broken, both rail covers were broken, hinge plate screws were missing, lower eject lever was broken on the personal computer memory card slot and the device failed left antenna test.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was returned for evaluation.There was no patient involvement.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• Brand Name: CARELINK PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10493043
• MDR Text Key: 205639354
• Report Number: 2182208-2020-01744
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1